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NCT05681468
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
Conditions: PreDiabetes, Diabetes Mellitus, Type 2, Overweight and Obesity
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 175
Sponsor: University of Alberta
Location: Canada
Summary
The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes.
The main question[s] it aims to answer are:Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C).Effects on systemic inflammation and immune function.Safety and adherence to interventions.Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet.Comparisons among groups at 3 and 6 months of intervention will be conducted.
Eligibility Criteria
Inclusion Criteria:Having overweight or obesity and HbA1C ≥ 5.7% at screeningExclusion Criteria:Individuals with specific nutritional habits preventing them from adhering to nutritional recommendationspregnant womenpeople on dialysis or recommended to follow a low-protein diet (base on glomerular filtration rate)familial hypercholesterolemia or hypertriglyceridemiatransitioning trans-gendertransitioning menopausal women.
Source: ClinicalTrials.gov (NCT05681468). StuddyBuddy aggregates publicly available trial information.